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更新于 今天

Sr. Regulatory Sciences Manager

4-5萬
  • 北京東城區(qū)
  • 5-10年
  • 本科
  • 全職
  • 招1人

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  • 同事很nice
  • 團(tuán)隊(duì)執(zhí)行強(qiáng)
  • 工作環(huán)境好
  • 人際關(guān)系好
  • 氛圍活躍
  • 實(shí)力大公司

職位描述

醫(yī)學(xué)
Use Your Power for Purpose At Pfizer, we're dedicated to bringing medicines to the world faster without compromising on excellence and integrity. Adhering to both local and global regulations is crucial, and the constantly evolving regulatory landscape demands forward-thinking and meticulous attention to detail. Your commitment and expertise are vital in expanding and accelerating patient access to Pfizer's medicines and vaccines. What You Will Achieve In this role, you will: ● Develop and lead innovative projects across the division, creating comprehensive plans to meet objectives and manage complex projects ● Formulate and implement regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations, and lifecycle management ● Provide strategic contributions to country or cluster markets, supporting leadership teams and fostering strong partnerships ● Understand, monitor, and assess the impact of local regulations and trends in the regulatory environment on key stakeholders ● Ensure compliance with local regulations by maintaining licenses, implementing corporate regulatory processes, SOPs, and systems, and ensuring team training ● Update the Local Product Document (labeling) in line with relevant regulations and SOPs ● Implement systems, processes, and procedures to enhance regulatory strategy productivity and facilitate information sharing across relevant lines ● Deliver project/product strategies, including label and risk assessments for assigned projects/products, ensuring business compliance and adherence to regulatory standards ● Develop and strengthen relationships with key external agencies to support the development and implementation of registration strategies Here Is What You Need (Minimum Requirements) ● A BA/BS with at least 6 years of experience or MBA/MS with at least 5 years of experience or PhD/JD with at least 1 year of experience or MD/DVM with any years of experience ● Deep understanding of both Regional and Global regulatory environments ● Comprehensive knowledge of drug development practices, rules, regulations, and guidelines ● Solid grasp of the business and financial environment ● Strong project management skills ● Ability to manage multiple projects simultaneously ● Excellent communication and negotiation skills Bonus Points If You Have (Preferred Requirements) ● Master's degree with 7+ years of experience or a Doctorate (PhD/PharmD/JD) with 4+ years of experience ● Strategic thinking and problem-solving skills ● Experience in leading cross-functional teams ● Proficiency in regulatory submission and approval processes ● High level of attention to detail and organizational skills Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates. Regulatory Affairs #LI-PFE

工作地點(diǎn)

北京東城區(qū)五礦廣場

職位發(fā)布者

劉一飛/人事經(jīng)理

昨日活躍
立即溝通
公司Logo輝瑞投資有限公司公司標(biāo)簽
輝瑞公司(Pfizer Inc.)創(chuàng)建于1849年,總部位于美國紐約,是一家以科學(xué)為基礎(chǔ)的、創(chuàng)新的、以患者為先的生物制藥公司。輝瑞的使命是“為患者帶來改變其生活的突破創(chuàng)新”。在輝瑞,我們通過科學(xué)和全球資源為人們提供治療方案,以延長其生命,顯著改善其生活。在醫(yī)療衛(wèi)生產(chǎn)品的探索、研發(fā)和生產(chǎn)過程中,輝瑞始終致力于奉行嚴(yán)格的質(zhì)量、安全和價(jià)值標(biāo)準(zhǔn)。我們在全球的產(chǎn)品組合包括創(chuàng)新藥品和疫苗。每天,輝瑞在發(fā)達(dá)和新興市場的員工都在推進(jìn)人類健康,推動(dòng)疾病的預(yù)防、治療和治愈,以應(yīng)對挑戰(zhàn)我們這個(gè)時(shí)代的頑疾。輝瑞還與醫(yī)療衛(wèi)生服務(wù)方、政府和社區(qū)合作,支持并促進(jìn)世界各地的人們能夠獲得更為可靠和可承付的醫(yī)療衛(wèi)生服務(wù)。這與輝瑞作為一家全球卓越的創(chuàng)新生物制藥公司的責(zé)任是一致的。170余年來,輝瑞一直致力于為所有依賴我們的人帶來改變。輝瑞于1989年進(jìn)入中國市場。扎根中國30余年,輝瑞已成為在華主要的外資制藥公司之一。2021年是輝瑞新征程的開始。迄今已有170余年歷史的輝瑞正在邁入全新時(shí)代,成為一家以科學(xué)為基礎(chǔ)的、創(chuàng)新的、以患者為先的生物制藥公司。目前輝瑞在中國業(yè)務(wù)覆蓋全國300余個(gè)城市,累計(jì)投資超過15億美元,并設(shè)立了1家先進(jìn)的生產(chǎn)設(shè)施,2個(gè)研發(fā)中心(分別位于上海張江高科技園區(qū)和武漢光谷),在華有近7,000名員工分布于業(yè)務(wù)、研發(fā)和生產(chǎn)等領(lǐng)域。輝瑞在華上市了五大領(lǐng)域的高品質(zhì)創(chuàng)新產(chǎn)品,包括腫瘤、疫苗、抗感染、炎癥與免疫、罕見病等多個(gè)領(lǐng)域的處方藥和疫苗,強(qiáng)大完善的產(chǎn)品線旨在滿足生命各階段的健康需求。
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